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Diss Factsheets
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EC number: 946-037-4 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
There were no studies available in which the toxicokinetic properties of the registered substance were investigated.
The registered substance is a liquid at 20°C, with the 10 major constituents, representing more than 80% of the substance, having a molecular weight between 134 and 204 g/mol. These constituents have limited water solubility (between 0.0844 - 14.3 mg/L), consequently, these constituents are lipophilic with log Kow>4.
The available evidence suggests that the substance is bioavailable via the oral and dermal routes. The substance is expected to be metabolised and mainly excreted in urine with low potential for bioaccumulation.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
In accordance with the section 8.1.1 of Annex VIII of Regulation (EC) No 1907/2006 (REACH), the toxicokinetic profile of the substance (i.e. absorption, distribution, metabolism and elimination) was derived from the relevant available information collated in the dossier. The physical chemical characteristics of the substance, the results obtained from acute, repeated-dose, and reproductive toxicity studies on the substance were used to predict its toxicokinetic behaviour.
Physico-chemical properties:
The substance is a UVCB substance with 10 known constituents accounting for more than 80% of the substance. They have a relatively low molecular weight between 134 and 204 g/mol. The substance is a limited water-soluble liquid (<14 mg/L). Consequently, it is mainly lipophilic based on the octanol/water partition coefficient (Log Kow >4 at 25°C except for 2 constituents with log Kow around 6.3 but accounting for less than 5% of the substance). The substance has moderate volatility according to the vapour pressure of the constituents (between 2.91 and 651 Pa at 25 °C).
Absorption:
Oral/GI absorption
The physical chemical characteristics described above suggest that the substance could slightly be absorbed in the gastro-intestinal tract by passive diffusion. However, some evidence of oral absorption were evidenced in acute oral toxicity study with lethargy observed after single dose administration at 5000 mg/kg bw of the read-across substance Pepper black oil although no mortality was recorded.
The observation of such systemic effects indicates the oral bioavailability of the registered substance and/or its metabolites.
In light of these data, and the lack of specific information on oral absorption, the substance was assumed to be 100% bioavailable by oral route for the purposes of human health risk assessment.
Dermal absorption
Regarding dermal absorption, systemic absorption by the dermal route is expected to be limited but to occur based on the Log Kow of most of the main constituents (slightly > 4) and the low molecular weight (< 500 g/mol) although no systemic clinical signs were observed in the acute dermal toxicity study up to 2000 mg/kg bw.
In light of these data, the substance was conservatively assumed to be 100% bioavailable by dermal route for the purposes of human health risk assessment.
Respiratory absorption
The potential for inhalation toxicity was not evaluated in vivo.
The vapour pressure of the substance (Vp = 2.91-651 Pa at 25°C with most constituents > 100 Pa) indicates a moderate volatility and inhalability and therefore exposure by inhalation may occur. Thus, at ambient temperature, respiratory absorption is expected under normal use and handling of the substance. Also, when used as a vapour or in aerosol, the substance is expected to be directly absorbed across the respiratory tract epithelium by passive diffusion.
In light of these data, and the lack of specific information on respiratory absorption, the substance was conservatively assumed to be 100% bioavailable by inhalation for the purposes of human health risk assessment.
Distribution:
There is no experimental evidence to indicate distribution but the physico-chemical data suggests that wide distribution could occur. The log Kow value > 4 at 25°C suggests that the substance could accumulate in fatty tissues. However, distribution and bioaccumulation are highly dependent on the rate of biotransformation and elimination. Some of the main constituents like limonene are expected to be extensively metabolised. This may explain why no evidence of cumulative effects was observed from the repeated dose oral toxicity study.
Metabolism:
The two major constituents of the registered substance, alpha-pinene and limonene, are known to be extensively and rapidly metabolised and excreted principally via urine.
Excretion:
Biotransformation is expected and elimination of metabolites would most likely occur in urine, although elimination of conjugates in bile is possible. As the parent substance is relatively volatile, elimination via the lungs, in expired air could also be possible.
The registered substance has constituents with log Kow>4 at 25 °C and slightly above the criterion of 4.5 for bioaccumulation. However, these constituents are expected to be extensively metabolised therefore, the registered substance is considered to have low bioaccumulation potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.